Enrollment of Individuals From Racial and Ethnic Minority Groups in Gynecologic Cancer Precision Oncology Trials

Abstract

Objective: To characterize whether enrollment patterns in precision oncology clinical trials for gynecologic cancers reflect the racial and ethnic diversity of patients with gynecologic cancers in the United States.

Methods: ClinicalTrials.gov was queried to perform this cross-sectional review. We included precision oncology trials -defined as trials using molecular profiling of a tumor or the patient genome to identify targetable alterations to guide treatment-of ovarian, uterine, cervical, and vulvar cancers in the United States. National Cancer Institute Surveillance, Epidemiology, and End Results and United States Census Bureau data were used to estimate cancer burden and the expected number of trial participants by race and ethnicity for each gynecologic cancer. The ratio of actual-to-expected participants was calculated. A ratio greater than 1 signified overenrollment. A random effects meta-analysis was performed to assess the relative weights of individual trials.

Results: We identified 493 trials, 61 of which met inclusion criteria. There were 2,573 patients enrolled in ovarian cancer trials, 1,197 in uterine cancer trials and 162 in cervical cancer trials. Non-Hispanic White women were overrepresented overall (enrollment ratio 1.26, 95% CI 1.20-1.32) and across all cancer types on subgroup analysis. Asian women, non-Hispanic Black women, and Hispanic women were underrepresented overall (enrollment ratios 0.63, 95% CI 0.41-0.86; 0.51, 95% CI 0.36-0.66 and 0.30, 95% CI 0.23-0.36, respectively). In subgroup analyses, Asian women and non-Hispanic Black women were underrepresented in ovarian and uterine cancer trials and Hispanic women were underrepresented across all cancer types.

Conclusion: Non-Hispanic Black women, Asian women, and Hispanic women with gynecologic cancers are underrepresented in precision oncology trials. Few U.S.-based precision oncology trials exist for uterine and cervical cancers, which have a high burden of morbidity and mortality among racial and ethnic minority groups. Failure to equitably enroll patients who belong to racial and ethnic minority groups may perpetuate existing disparities in gynecologic cancer outcomes.